K-number	K131144
Device name	AMECO SHEATH INTRODUCER
Applicant	Ameco Medical Industries
Product code	DYB
Device class	Class II
Decision date	Aug 15, 2013
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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AMECO SHEATH INTRODUCER

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